NDC 80568-299 Isseey Antibacterial Alcohol Wet Wipes

Ethyl Alcohol, Benzalkonium Chloride

NDC Product Code 80568-299

NDC 80568-299-01

Package Description: 100 PACKAGE in 1 CANISTER > .13 mL in 1 PACKAGE

NDC 80568-299-02

Package Description: 100 PACKAGE in 1 CANISTER > .13 mL in 1 PACKAGE

NDC Product Information

Isseey Antibacterial Alcohol Wet Wipes with NDC 80568-299 is a a human over the counter drug product labeled by Isseey. The generic name of Isseey Antibacterial Alcohol Wet Wipes is ethyl alcohol, benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Isseey

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Isseey Antibacterial Alcohol Wet Wipes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 75 mL/100mL
  • BENZALKONIUM CHLORIDE .1 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Isseey
Labeler Code: 80568
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-23-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Isseey Antibacterial Alcohol Wet Wipes Product Label Images

Isseey Antibacterial Alcohol Wet Wipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

75% Ethyl Alcohol (12% v/v)Benzalkonium Chloride (0.10% v/v)

Purpose

Antiseptic

Uses

• Apply on skin and surface to decrease bacteria and germs that may cause disease • recommended for repeated use.

Directions

• Remove top cover • pull up wipe corner from center of the roll and thread through hole in the cover • open center cap on cover to remove wipe • unfold wipe to disinfect skin and surface • let air dry your skin and surface • dispose wipe after using • when done using, close center cap carefully to prevent loss moisture • when apply on dirty surface, you must clean with another wipe before disinfecting.

Warnings

For external use only: hand, arm, leg and surface.Flammable, keep away from fire, flame or heat.When using this product • keep out of eye, In case of contact with eyes, flush thoroughly with water • avoid contact with broken or sensitive skin • do not use on face • do not put on your mouth.Stop use ask a doctor if •irritation and redness develop • If the condition persists more than 72 hours consults with doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children • if put on mouth or swallowed, get medical help or contact a Poison Control Center right away.

Other Information

• Not recommended for infants use • for children under 6, must use under adult supervision • do not use as diaper wipe • rinse toys or food with clean water after disinfecting • do not use on unpainted wood • do not apply on dishes, glassware or utensils to disinfectStorage and disposal • store wipe in original container in a cool, or dry place • keep container tightly closed • do not reuse or refill this container • do not flush • dispose wipes after using and put container in the trash.

Inactive Ingredients

Purified Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Fragrance.

* Please review the disclaimer below.